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Suggested Citation:"ORGANIZATION OF THE REPORT." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Page 23

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INTRODUCTION, BACKGROUND, AND DEFINITIONS 23 1 Introduction, Background, and Definitions Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. Principle 7, the Nuremberg Code The protection of individuals who volunteer to participate in research is essential to the ethical conduct of research. Such protections were not explicitly and systematically addressed in the United States, however, until the late 1940s, when scientists and policy makers recognized the need to respond to crimes committed by Nazi scientists during World War II. Since then national and international policies have evolved to create a system of protections requiring the involvement of investigators, research sponsors, research institutions, health care providers, federal agencies, and patient and consumer groups. This evolution is worth tracking to appreciate what brings this report to the forefront at this time; that is, how can this complex system of protections be assessed in a reliable and valid way to ensure that it is effective, efficient, and accountable—that “proper preparations” have been made and that “adequate facilities” have been provided to protect the experimental subjects of research? ORGANIZATION OF THE REPORT Before beginning the discussion leading to the recommendations contained within this report, the committee notes that this document focuses narrowly on

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Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.

In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

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